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“While I have received an honoraria from for this program,and discuss dabigatran/Pradaxa from Boehringer Ingelheim, the information presented provides an unbiased overview of all products related to treating patients”.

He presents to the emergency department complaining of heart palpitations, dizziness and sweating.

“I’ve had this before, but boy, this time it’s really intense, and it’s not going away.”

About 1 week ago Mike had a “spell”. While eating dinner he suddenly stopped speaking, the right side of his mouth drooped, the fork fell from his hand. This episode lasted 20 minutes. Mike did not go to the ED.

*Aspirin is a reasonable alternative in some as indicated by risk/benefit

Consider stroke risk vs. bleeding risk

Only when the stroke risk is low and bleeding risk is high does the risk/benefit ratio favour no antithrombotic therapy

CCS 2012 Recommendation: All patients with AF [paroxysmal, persistent or permanent] or atrial flutter should be stratified using predictive index for stroke risk [e.g., CHADS2 ] and for risk of bleeding [e.g., HAS-BLED] and that most patients receive either OAC or ASA.

Mike was switched from warfarin to dabigatran 150 mg BID, and discharged from the emergency department.

The rationale for this decision is that the 150mg BID dose of dabigatran has superior efficacy compared to well-controlled warfarin in preventing ischemic stroke, as well as decreased incidence of major bleeding compared to warfarin.

Dabigatran 110mg was not chosen because this dose is reserved for elderly patients (usually over 80), and patients with increased bleeding risks, neither of which is the case with Mike.

Rivaroxaban 20mg daily was not chosen for this patient because rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism in ROCKET-AF. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. With this knowledge, the advantages are greater with dabigatran than rivaroxaban for this patient.

Apixaban 5mg BID was not chosen for this patient because although ARISTOTLE has similar profile , the treating physician was more familiar with dabigatran because it has been on the market longer and more clinical and practical data are available to support its use in this patient.

Of note, no head-to-head comparisons in patients at risk of stroke were made with each OAC, and therefore clinical judgment should be applied, and review of trial data should help guide clinical decision making in the choice of OACs.

In general, it is preferable to wait at least 30 min to assess the effect of each therapy before initiating next therapy. FEIBA is a freeze dried sterile human plasma fraction that shortens the activated partial thromboplastin time (APTT)

Recent post-marketing reports of bleeding with dabigatran, when used for stroke prevention in patients with AF, have the potential to be misinterpreted and provide an inaccurate impression of the drug’s safety.

Bleeding with dabigatran must be interpreted in the context of its benefits (see next slide).

Both dabigatran and warfarin are likely to be associated with higher rates of bleeding in clinical practice than those observed in randomized controlled trials such as RE-LY, because patients included in trials tend to be healthier than in the general community.

However, differences in bleeding rates (ICH), between RE-LY and the general community are likely to be even greater for warfarin than dabigatran because both the INR and blood pressure control (the single most important predictor of ICH during warfarin therapy) were much better in RE-LY than in average clinical practice.

Those with access to databases from provincial, national or insurance registries are encouraged to report the relative use of various antithrombotic therapies for AF and the rates of thrombotic and bleeding events.